Title	REGULATORY AFFAIRS PROJECT MANAGER
Location	Southwest
Company	Fortune 100 Medical Manufacturing Company
Package	$45,000 - $75,000
Primary Accountabilities and Responsibilities                                                                 - Establishment of global regulatory/legal   requirements/strategies for launch and   continued marketing of entire product line - Submission and approval of all required US regulatory   documents (510(k)s, NDAs and ANDAs) - Preparation of all required international registration   packages - Establishment of safety data portfolios for product   line - Approval of all product specifications, labeling,   material safety data sheets, advertisements,   etc. as necessary for launch
Credentials / Knowledge / Skills Preferred                                                                 - Bachelor's of science in chemistry, biology or health   science - Minimum of 3 years in direct experience in FDA   regulation of drugs, preferably OTC   antimicrobial/skin protectant products - International regulatory experience with this product   line preferred - Good global communication skills and ability to   prepare well written regulatory documents - Strong organizational skills, with the ability to   handle multiple tasks simultaneously